Update on Low Risk Trials: Current Indications and Guidelines ......STATE OF AORTIC VALVE...
Transcript of Update on Low Risk Trials: Current Indications and Guidelines ......STATE OF AORTIC VALVE...
Update on Low Risk Trials:Update on Low Risk Trials:Current Indications andCurrent Indications and
Guidelines for TAVRGuidelines for TAVR
SCRIPPS CLINIC
Paul S. Teirstein
Chief of Cardiology
Director, Interventional Cardiology
Scripps Clinic
Disclosure Statement of Financial InterestDisclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financialinterest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
Grant/Research Support Boston, Abbott, Medtronic, Edwards
Consulting Fees/Honoraria Boston, Abbott, Medtronic, Edwards
President (unpaid) NBPAS
SCRIPPS CLINIC
Things that upset me, pretty much every day
• Our new “EPIC” electronic health record• My cable bill• My wife’s driving• ….• Pretty much everyday…I say to myself…
SCRIPPS CLINIC
• Pretty much everyday…I say to myself…“Why didn’t I invent TAVR?”
STATE OF TAVR IN THE USDRAMATIC GROWTH
24,927
38,159
42,605
30,000
35,000
40,000
45,000
Commercial TAVR Cases(TVT-R)
24,927
38,159
42,605
29,829 30,26528,493
25,58030,000
35,000
40,000
45,000
AVR and TAVR Volumes(STS & TVT-R)
TAVR
AVR
4
4,503
8,977
16,308
24,927
0
5,000
10,000
15,000
20,000
25,000
30,000
2012 2013 2014 2015 2016 2017
16,308
24,927 25,580
0
5,000
10,000
15,000
20,000
25,000
30,000
2014 2015 2016 2017E*
Source: STS/ACC TVT Registry Database as of 3-1-18, presented by Carroll, CRT 2018
Transcatheter Valve Hemodynamics | May 2018
STATE OF AORTIC VALVE REPLACEMENT IN THE US31% GROWTH IN TOTAL AORTIC VALVE PROCEDURES SINCE 2014 (TAVR &SAVR)
64,085
84,095
50,000
60,000
70,000
80,000
90,000
Total AVRs
5
-
10,000
20,000
30,000
40,000
50,000
2014 2017
Source: STS/ACC TVT Registry Database as of 3-1-18, presented by Carroll, CRT 2018
Transcatheter Valve Hemodynamics | May 2018
STATE OF TAVR IN THE USMEAN AGE IS DROPPING
82
81 81
82
83
Mean Patient Age
6
81 81
80
79
80
81
2014-R4Q 2015-R4Q 2016-R4Q 2017-Q2R4Q
Source: STS/ACC TVT Registry Database as of 3-1-18, presented by Carroll, CRT 2018
Transcatheter Valve Hemodynamics | May 2018
CONTINUED TAVR EXPANSIONONGOING STUDIES IN YOUNGER & HEALTHIER PATIENTS
7
*Investigational use only
*
Transcatheter Valve Hemodynamics | May 2018
Low Risk/TF ASSESSMENT by Heart TeamLow Risk/TF ASSESSMENT by Heart Team(STS < 4%)(STS < 4%)
1:1 Randomization1:1 Randomization
Symptomatic Severe Aortic Stenosis
PARTNER 3 Study Design3 Study Design
1:1 Randomization1:1 Randomization10001000 PatientsPatients
TAVR(SAPIEN 3 THV)
Surgery(Surgical Bioprosthetic Valve)
Follow-up: 30 day, 6 mos, and annually through 10 years
PRIMARY ENDPOINT:Composite of all-cause mortality, stroke, or CV re-hospitalization
at 1 year post-procedure
Primary Endpoint
TAVRSurgery
De
ath
,S
tro
ke
,o
rR
eh
osp
(%)
Pnon-inferiority< 0.001
Upper 95% CI ofrisk diff = -2.5%
8.5%8.5%9.3%
15.1%
10
20
0 3 6 9 12
496 475 467 462 456454 408 390 381 377
Number at risk:Number at risk:
TAVRSurgery
Months after Procedure
451374
Psuperiority= 0.001
HR [95% CI] =0.54 [0.37, 0.79]
De
ath
,S
tro
ke
,o
r
4.2%4.2%
0
All-Cause MortalityC
au
se
Mo
rta
lity
(%)
10
20HR [95% CI] =
0.41 [0.14, 1.17]
P = 0.09
TAVRSurgery
All-
Ca
use
Mo
rta
lity
(%)
494 494 493 492454 445 438 433 431
488427
Months from ProcedureNumber at risk:Number at risk:
1.0%1.0%1.1% 2.5%
00.4%0.4%
496TAVRSurgery
0 3 6 9 12
All StrokeA
llS
tro
ke
(%)
HR [95% CI] =0.38 [0.15, 1.00]
P = 0.04
10
20
TAVRSurgery
All
Str
oke
(%)
491 491 489 487454 435 427 423 421
484417
Months from ProcedureNumber at risk:Number at risk:
496TAVRSurgery
1.2%
2.4% 3.1%
00.6%0.6%0 3 6 9 12
Primary Results From the Evolut Low Risk TrialPrimary Results From the Evolut Low Risk Trial
Michael J. Reardon, MD, FACCHouston Methodist DeBakey Heart & Vascular Institute, Houston, TXFor the Evolut Low Risk Trial Investigators
Evolut Low Risk Trial
*Additional patients were randomized to permit completion of the LTI substudy and to enroll a Japanese cohort.
6.4%8%
10%
12%
Clinical ImplicationsDeath, Disabling Stroke and Heart Failure Hospitalizations to 1 Year
Esti
mat
edK
Mra
tes,
%
Composite Rates
TAVR SAVR Difference = –4.5%
5.6% 10.2% P = 0.002
2.3%[VALUE]
0.7%
2.3%3.1%
0%
2%
4%
6%
TAVR SAVR
Esti
mat
edK
Mra
tes,
%
Death
Disabling Stroke
HF Hospitalization
Bayesian rates as %TAVR
(N=725)SAVR
(N=678)(95% BCI forDifference)
All-cause mortality or disabling stroke 2.9 4.6 (-4.0, 0.4)
All-cause mortality 2.4 3.0 (-2.6, 1.3)
Cardiovascular mortality 1.7 2.6 (-2.7, 0.7)
All stroke 4.1 4.3 (-2.4, 1.9)
Disabling stroke* 0.8 2.4 (-3.1, -0.3)
Clinical Outcomes at 1 Year
Disabling stroke* 0.8 2.4 (-3.1, -0.3)
Transient ischemia attack 1.7 1.8 (-1.6, 1.3)
Myocardial infarction 1.7 1.6 (-1.3, 1.5)
Endocarditis 0.2 0.4 (-0.9, 0.5)
Valve thrombosis 0.2 0.3 (-0.9, 0.5)
Aortic valve reintervention 0.7 0.6 (-1.0, 0.9)
Heart failure hospitalization* 3.2 6.5 (-5.9, -1.0)
* Significantly favors TAVR BCI = Bayesian credible interval
• TAVR a clear cut overall winner over SAVR
• What’s left?• Long term results
• Expanded indications, improved technique, improved TAVR devices
SCRIPPS CLINIC
Structural Valve Deterioration
Meta analysis of 12 studiesDefinitions of structural valve deterioration varied somewhat
FiveFive--Year Outcomes after RandomizationYear Outcomes after Randomizationto Transcatheter or Surgical Aortic Valveto Transcatheter or Surgical Aortic ValveReplacement: Final Results of TheReplacement: Final Results of ThePARTNER 1 TrialPARTNER 1 TrialPARTNER 1 TrialPARTNER 1 Trial
Michael J. Mack, MDMichael J. Mack, MDon behalf of The PARTNER Trial Investigators
ACC 2015 | San Diego | March 15, 2015
N = 358InoperableInoperable
ASSESSMENT:ASSESSMENT:
PARTNER Study DesignPARTNER Study Design
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate3,105 Total Patients Screened
ASSESSMENT: High-Risk AVR Candidate3,105 Total Patients Screened
Total = 1,057 patients2 Parallel Trials:
Individually Powered
N = 699 High RiskHigh Risk
ASSESSMENT:ASSESSMENT:Yes No
N = 179
StandardTherapy
ASSESSMENT:
Transfemoral AccessASSESSMENT:
Transfemoral Access
Not In Study
TF TAVR
Primary Endpoint: All-Cause MortalityOver Length of Trial (Superiority)
Co-Primary Endpoint: Composite of All-Cause Mortalityand Repeat Hospitalization (Superiority)
1:1 Randomization
VS
Yes No
N = 179
TF TAVR SAVR
Primary Endpoint: All-Cause Mortality at 1 yr(Non-inferiority)
TA TAVR SAVRVSVS
N = 248 N = 104 N = 103N = 244
ASSESSMENT:
Transfemoral AccessASSESSMENT:
Transfemoral Access
Transapical (TA)Transfemoral (TF)
1:1 Randomization1:1 Randomization
Yes No
AllAll--Cause Mortality (ITT)Cause Mortality (ITT)All PatientsAll Patients
HR [95% CI] =1.04 [0.86, 1.24]
p (log rank) = 0.76
62.4%
67.8%
No. at Risk
TAVR 348 262 228 191 154 61
SAVR 351 236 210 174 131 64
Error Bars Represent95% Confidence Limits
Aortic Valve AreaAortic Valve Area
Error Bars =Error Bars = ±± 1 Std Dev1 Std Devp < 0.0001
TAVR 304 211 151 106 79 53
SAVR 294 154 121 84 60 46
5-Year Outcomes from the Randomized CoreValveUS Pivotal High Risk Trial: Final ResultsUS Pivotal High Risk Trial: Final Results
Thomas G. Gleason, MD; Michael J. Reardon, MD; Jeffrey J. Popma, MD; Joon
Sup Lee, MD; Steven J. Yakubov, MD; Neal S. Kleiman, MD; Stan Chetcuti,
MD; G. Michael Deeb, MD; David H. Adams, MD
for the CoreValve US Pivotal High Risk Trial Investigators
55--Year AllYear All--Cause MortalityCause Mortality –– High Risk PtsHigh Risk PtsCoreValve US Pivotal High Risk Trial
TAVR 391 336 301 253 205 135
SAVR 359 284 241 199 162 101
No. at risk
23[95% confidence intervals]
Valve PerformanceValve Performance
1.7 1.71.8
1.9 1.9
1.61.5 1.5
1.61.7
49.4
48.6
30.0
40.0
50.0
60.0
1.5
2.0
2.5
3.0TAVR
SAVR
no
Effe
ctiv
eO
rifi
ceA
rea,
cm2 M
eanG
radien
t,mm
Hg
P < 0.01 for TAVR vs. SAVR at all follow-up time points
CoreValve US Pivotal High Risk Trial
24
0.7
0.7
8.9 8.4 7.7 7.4 7.1
12.211.9 11.4 11.2 10.9
0.0
10.0
20.0
Baseline 1 Year 2 Years 3 Years 4 Years 5 Years0.0
0.5
1.0
Effe
ctiv
eO
rifi
ceA
rea,
cmM
eanG
radien
t,mm
Hg
TAVR AVG 391 303 250 193 152 112
SAVR AVG 359 230 188 141 114 88
TAVR EOA 384 284 238 182 144 99
SAVR EOA 353 210 174 134 106 84
2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document:
TAVR Guidelines
• There are currently 587 sites in the U.S. performing TAVR, up from just 156 in 2012
• Recommendation: Existing TAVR programs meet certain requirements. Specifically, at least50 TAVRs per year, or 100 over two years, and at least 30 SAVRs over one year, or 60 overtwo years. This is an increase from the current NCD that specifies 20 annual TAVRs.
• Beyond number of procedures performed, centers must now track the number of other
SCRIPPS CLINIC
• Beyond number of procedures performed, centers must now track the number of otherquality metrics focused on morbidity, mortality, and quality of life at certain time points post-TAVR.
• Recommendation: Centers implement a quality assessment and improvement processincluding active participation in a registry, quarterly meetings of the multidisciplinary team,and documentation of appropriate-use criteria in the patient selection process.
• Two-surgeon sign-off requirement dropped…only one surgeon sign off required.• But why don’t we need an interventional cardiologist to sign off on SAVR?
• TAVR institution must have a trained TAVR physician on the heart team. Either acardiothoracic surgeon or an interventionalist, should have at least 100 transfemoral TAVRprocedures under their belt, with at least 50 of those as the primary operator. Themultidisciplinary heart team also needs to include a cardiac surgeon who has performed atleast 100 SAVRs over their lifetime or 50 SAVRs over two years, with at least 20 of those inthe previous year. This cardiac surgeon also must spend at least half their active practicetime with the TAVR program.
2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document:
TAVR Guidelines
SCRIPPS CLINIC
time with the TAVR program.
• The multidisciplinary heart team also needs to include a cardiac surgeon who has performedat least 100 SAVRs over their lifetime or 50 SAVRs over two years, with at least 20 of thosein the previous year.
The patient must be under the care of a Heart Team
The heart team includes the following:
Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aorticstenosis who have:
a. independently examined the patient face-to-face, evaluated the patient’s suitability for surgicalaortic valve replacement (SAVR), TAVR or medical or palliative therapy;
CMS National Coverage Decision: 2019
SCRIPPS CLINIC
aortic valve replacement (SAVR), TAVR or medical or palliative therapy;b. documented and made available to the other heart team members the rationale for their clinical
judgment.Providers from other physician groups as well as advanced patient practitioners, nurses, researchpersonnel and administrators.
The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR
Qualifications to begin a TAVR program for hospitals without TAVR experience:The hospital program must have the following:
a.≥ 50 open heart surgeries in the previous year prior to TAVR program initiation, and;b.≥ 20 aortic valve related procedures in the 2 years prior to TAVR program initiation, and;c.≥ 2 physicians with cardiac surgery privileges, and;d.≥ 1 physician with interventional cardiology privileges, and;e.≥ 300 percutaneous coronary interventions (PCIs) per year.
CMS National Coverage Decision: 2019
SCRIPPS CLINIC
e.≥ 300 percutaneous coronary interventions (PCIs) per year.
The heart team must include:a.Cardiovascular surgeon with:
a. ≥ 100 career open heart surgeries of which ≥ 25 are aortic valve related; and,b.Interventional cardiologist with:
a. Professional experience of ≥ 100 career structural heart disease procedures; or, ≥ 30 left-sided structural procedures per year; and,
b. Device-specific training as required by the manufacturer.
Qualifications for hospital programs with TAVR experience:
The hospital program must maintain the following:
a.≥ 50 AVRs (TAVR or SAVR) per year including ≥ 20 TAVR procedures in the prior year ; or,b.≥ 100 AVRs (TAVR or SAVR) every 2 years, including ≥ 40 TAVR procedures in the prior 2 years; and,c.≥ 2 physicians with cardiac surgery privileges; and,d.≥ 1 physician with interventional cardiology privileges, and
CMS National Coverage Decision: 2019
SCRIPPS CLINIC
d.≥ 1 physician with interventional cardiology privileges, ande.≥300 percutaneous coronary interventions (PCIs) per year;and,
1.The heart team and hospital are participating in a prospective, national, audited registry that: 1)consecutively enrolls TAVR patients; 2) accepts all manufactured devices; 3) follows the patient for atleast one year
2.The following outcomes must be tracked by the registry;
1. Stroke;
CMS National Coverage Decision: 2019
SCRIPPS CLINIC
1. Stroke;2. All-cause mortality;3. Transient Ischemic Attacks (TIAs);4. Major vascular events;5. Acute kidney injury;6. Repeat aortic valve procedures;7. New permanent pacemaker implantation;8. Quality of Life (QoL).
The registry shall collect all data necessary and have a written executable analysis plan in place toaddress the following questions…
i.When performed outside a controlled clinical study, how do outcomes and adverse events compare tothe pivotal clinical studies?
ii.What is the long term durability of the device?iii.What are the long term outcomes and adverse events?
CMS National Coverage Decision: 2019
SCRIPPS CLINIC
iii.What are the long term outcomes and adverse events?iv.What morbidity and procedure-related factors contribute to TAVR patients outcomes?
TVT Registry Report Example
From: Bob Strange [[email protected]]Sent: Monday, December 10, 2018 9:31 PMTo: Stinis, Curtiss T; Lutes, JenniferSubject: [External] Thanks for the TAVR procedure Dr. Stinis
WARNING! External email. Handle links and/orattachments with caution. IS Service Desk @ 858-678-7500
May 8th, immediately after my TAVR procedure, you told me that I could do anything I wanted after one week forthe groin stitches to heal. I walked several blocks every day, even the first morning home from my overnight stay atScripps.
Weightlifting Workouts at the gym also went well the 8th day.I prepared and painted the complete exterior of our stucco exterior home with a roller and brush during the rest ofMay.
This photo of an 80 Kilo overhead clean and jerk was taken of me at a national USA masters Olympic weightliftingcompetition November 2nd at Salt Lake City. I also did a 60 kilo Olympic snatch.This is not much weight for a young athlete, but both lifts and the total are national records for a male in the 80-85age group weighing less than 89 kilos. The records are kept by age and weight classes. I was awarded best lifter forthe entire competition involving several hundred competitors.
Thank you and your team for providing me an extension of an active, healthy lifestyle far beyond what would haveoccurred without your TAVR procedure.
82 yo 6 months post TAVR